GeneMatch: A Program of the Alzheimer's Prevention Registry to Match Individuals to Studies Based on Apolipoprotein E (APOE) Genotype

Alzheimer Disease Clinical Trial

Official title:

Alzheimer's Prevention Registry GeneMatch Program

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02564692
• Other study ID #: APR-001
• Status: Recruiting
• Start date: November 2015
• Est. completion date: December 2030

Study information

• Verified date: August 2023
• Source: Banner Health
• Contact: David Gordon, MS
• Phone: 1-888-STOP-ALZ
• Email: GeneMatch[@]endALZnow.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The purpose of the Alzheimer's Prevention Registry GeneMatch program is to identify a large group of people interested in participating in research studies or clinical trials based in part on their genetic background. This genetic information will be used to match interested individuals to studies, providing a recruitment resource to the Alzheimer's scientific community. Interested individuals should visit www.endALZnow.org/GeneMatch to join the GeneMatch program.

Description:

The primary objectives of the Alzheimer's Prevention Registry GeneMatch program are to (1) identify and characterize a large cohort of people who are interested in, and may be eligible to participate in, current and future preclinical Alzheimer's disease research studies and clinical trials based on their genetic background, and (2) provide information to these individuals about research studies for which they may be eligible, based in part on their genetic background. Cognitively unimpaired individuals age 50 to 90, inclusive, are eligible to enroll in GeneMatch. GeneMatch will provide participants with a genetic sample kit (a cheek swab) to test for a specific gene called apolipoproteins E (APOE). GeneMatch does not disclose the results of the APOE test to participants. GeneMatch may use the APOE test results to match participants to research studies. Participants are under no obligation to pursue these study opportunities.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500000
• Est. completion date: December 2030
• Est. primary completion date: December 2030
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

Inclusion Criteria:

• Age 50-90, inclusive
• Provide basic demographic, medical history, and contact information
• Consent to APOE genotyping without receiving results
• Live in the United States

Exclusion Criteria:

• Unable to comply with this project's protocol requirements
• Self-reported diagnosis of dementia or any other objective cognitive impairment syndrome

Related Conditions & MeSH terms

• Alzheimer Disease

Locations

Country	Name	City	State
United States	Banner Alzheimer's Institute	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Banner Health

Country where clinical trial is conducted

United States, 

References & Publications (1)

Langbaum JB, Karlawish J, Roberts JS, Wood EM, Bradbury A, High N, Walsh TL, Gordon D, Aggarwal R, Davis P, Stowell C, Trisko L, Langlois CM, Reiman EM, Tariot PN. GeneMatch: A novel recruitment registry using at-home APOE genotyping to enhance referrals — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of individuals who enroll in GeneMatch		15 years
Secondary	Number of individuals referred to research studies		15 years
Secondary	Number of individuals who enroll in research studies		15 years